As previously reported (here), Dr. Reddy’s generic of Nexium was too close to that of the innovator’s “Purple Pill”. Apparently, the firm has changed the color of its capsule and reintroduced the product. But, this does reinforce that fact that generic companies, despite the Office of Generic Drugs’ (OGD) input, desire to have the generics look more like their brand name counterparts.
FDA has given new notice to registered pharmacy outsourcing facilities that it is prepared to take aggressive enforcement action against serious violators. In one of its first major enforcement actions of 2016, a Consent Decree of Permanent Injunction was entered on January 8th against Downing Labs (formerly NuVision), a Dallas, Texas outsourcing facility manufacturing both non-sterile drug products and injectable drugs.
Not too often do you see the public gather around an idea so emphatically and in such numbers. This struck me when I was looking through the public comments on Docket FDA-2014-N-1207. To date, there are about 3000 comments posted; all are available on regulations.gov. The issue of the docket relates to the use of […]
The FDA has updated its pediatric exclusivity page (here); a search of the document reveals 9 different products received pediatric exclusivity during 2015.The number of awards of pediatric exclusivity in 2015 are substantially higher than the numbers from 2013 or 2014, when 6 awards were made in each of those years. What will 2016 bring?
Recently, FDA took administrative action by detaining at the border a product containing kratom, a plant material that may have the potential for abuse and potential serious health consequences. Then the Department of Justice filed a complaint in US District Court on behalf of the FDA “alleging, among other things, that kratom is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that it does not present a significant or unreasonable risk of illness or injury; therefore, dietary supplements containing kratom are adulterated under the FD&C Act.”
I am pleased to announce that effective January 1, 2016, Frances “Fran” Zipp is President & Chief Executive Officer of Lachman Consultants.
OGD partially updated its Generic Drugs Activity Report for FY 2016 this morning and it must have found a few more receipts.
The Department of Justice (DOJ) and its federal partners are being very vocal about turning up the heat on compounders and dietary supplement manufacturers and marketers in 2016 and beyond. 2016 is guaranteed to be a record year for enforcement actions against manufacturers of these products that are not in compliance with the regulatory framework governing their manufacture and distribution.
FDA recently released a revised draft Guidance outlining its new thinking on the bioequivalence requirements for paliperidone palmitate, representing still another BE guidance revision for a long-acting product, but this time for a long-acting parenteral suspension of this product for schizophrenia. The original draft BE Guidance document for this injectable suspension was issued in August 2011.
December, the last month of the calendar year, may (we hope) represent the new normal in the approval of generic drugs. But there may also be signs of concern regarding submissions on the horizon. The Office of Generic Drugs (OGD) had a modern day record in December with 79 full approvals and 20 tentative approvals for a total of 99 approval actions for original ANDAs for the month.
